Botox Cosmetic: Uses, Side Effects and Dosage

What is Botox Cosmetic used for?

Botox Cosmetic is used in adults to:

• treat upper facial lines, including forehead, crow’s feet, and frown lines.
• improve the appearance of vertical neck bands connecting the jaw and neck (platysma prominence).

How does Botox Cosmetic work?

Botox Cosmetic is a muscle relaxant. When injected into muscles, it blocks part of the nerve signals (impulses) to those muscles. It also reduces the movement of those muscles. This causes muscle relaxation, which goes away over time.

What are the ingredients in Botox Cosmetic?

Medicinal ingredient: OnabotulinumtoxinA

Non-medicinal ingredients: Albumin (human) and sodium chloride.

Serious Warnings and Precautions

Botox Cosmetic comes in the following dosage forms:

Sterile vacuum-dried concentrate; powder for solution for injection; 50 and 100 Allergan Units per vial.

Do not use Botox Cosmetic if:

• you are allergic or sensitive to any of the ingredients.
• you have an infection in the muscles where Botox Cosmetic is injected.
• you have any muscle disorders, such as myasthenia gravis, Eaton Lambert Syndrome or amyotrophic lateral sclerosis.

To help avoid side effects and ensure proper use, talk to your doctor or healthcare professional before you take Botox Cosmetic. Talk about any health conditions or problems you may have, including if you:

• have myasthenia gravis or Eaton Lambert Syndrome, amyotrophic lateral sclerosis or another muscle disorder.
• are allergic or sensitive to Botox Cosmetic.
• have an infection at a proposed injection site.
• are scheduled to have surgery using a general anaesthetic (a medicine that reduces your sensitivity to pain).
• are taking or are likely to take antibiotics, especially aminoglycoside antibiotics.

• are pregnant or become pregnant while taking this drug. Botox Cosmetic given to pregnant rabbits caused abortion or birth defects.

• are nursing. We don’t know yet if this drug gets into human milk and can be passed to your baby.

Botox Cosmetic is for intramuscular use only.

Other warnings you should know about:

Seek immediate medical care if swallowing, speech or respiratory problems arise.

Tell your healthcare professional if you experience any difficulties in swallowing food while on Botox Cosmetic, as it could be related to the dosage. Difficulty in swallowing food, ranging from very mild to severe, can persist for 2 to 3 weeks after injection, or longer.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Botox Cosmetic:

The effect of Botox Cosmetic may be increased by aminoglycoside antibiotics (e.g., streptomycin, tobramycin, neomycin, gentamicin, netilmicin, kanamycin, amikacin), spectinomycin, polymyxins, tetracyclines, lincomycin or any other drugs that interfere with neuromuscular transmission.

How to take Botox Cosmetic:

Botox Cosmetic will be given to you by a healthcare professional in a healthcare setting.

• Intramuscular Use

Usual dose:

Botox Cosmetic is injected into your muscles (intramuscularly). It is injected directly into the affected area of your body. Your healthcare professional will usually inject Botox Cosmetic into several sites within each affected area.

A unit of Botox Cosmetic is a dose measurement that is specific to Botox Cosmetic and cannot be interchanged with the units used to measure other botulinum toxin products.

The amount in your injection and how long the effect will last depends on the reason you are taking Botox Cosmetic (forehead, crow’s feet, frown lines, platysma prominence, or combination of all). Therefore, your healthcare professional will decide how much, how often, and in which muscle(s) Botox Cosmetic will be given to you. Your healthcare professional should use the lowest effective dose that works for your condition. Your dose can be increased in subsequent treatments if needed.

The effects last about 4 months for upper facial lines and platysma prominence. You cannot receive another treatment sooner than 3 months.

If you feel that the effect of Botox Cosmetic is not optimal, let your healthcare professional know. There are several potential reasons for this that your healthcare professional can assess.

Overdose:

What are possible side effects from using Botox Cosmetic?

These are not all the possible side effects you may feel when taking Botox Cosmetic. If you experience any side effects not listed here, contact your healthcare professional.

General

Pain, tenderness and/or bruising at the site of injection. Malaise (generally feeling unwell), lasting up to six weeks after injection with Botox Cosmetic. Weakness and rarely, changes in the way the heart beats, chest pain, skin rash and allergic reaction (symptoms: shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin).

The following side effects were reported in clinical trials for upper facial lines: headache, drooping eyelid, eyelid swelling, eyelid change, bruising under the skin, aching or itching forehead, double vision, asymmetric smile, skin tightness (including raising of the outer eyebrows), face pain, injection site pain/burning/stinging, swelling of the injection site, nausea, local muscle weakness, redness of the skin and abnormal sensation.

The following side effect was reported in clinical trials for platysma prominence: facial muscle weakness.

The following events have been reported rarely (< 0.1%) since Botox Cosmetic has been marketed: skin rash, itching, allergic reaction (including anaphylaxis), dysphagia, respiratory compromise, seizures, facial paralysis, dry mouth, abdominal pain, anorexia, diarrhea, vomiting, eye problems including glaucoma, double vision, blurred vision decreased eyesight, dry eye, ear problems including not hearing well, tinnitus, numbness in your face, localized muscle twitches, tiredness. There have also been rare reports after botulinum toxin treatment of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors, including cardiovascular disease.

Eyelid swelling has been reported following injections into the area around the eyes.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store the vacuum-dried product either in a refrigerator at 2 to 8^oC, or in a freezer at or below -5^o C.

Keep out of reach and sight of children.

If you want more information about Botox Cosmetic:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html); the manufacturer’s website www.abbvie.ca or by calling 1-888-704-8271.

Last Revised: APR 09, 2025

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